Table of Contents
Greystone Research has identified a branded drug that represents an attractive opportunity for generic drug companies that utilize the provisions under Section 505(j)(2)(A)(vii)(IV) as part of their ANDA-filing strategy. Details of our findings are contained in an insightful assessment, the highlights if which are presented below.
Eliquis (apixaban) is an oral Factor Xa inhibitor – essentially an anticoagulant - targeting stroke prevention in atrial fibrillation and the prevention and treatment of venous thromboembolic (VTE) disorders. It is currently approved in the EU, Canada and Japan for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors and for use in VTE prevention in adult patients who have undergone elective hip or knee surgery. In December 2012, the U.S. Food and Drug Administration (FDA) approved Eliquis to reduce the risk of stroke and systemic embolism in patients with NVAF.
Apixaban is one of a group of novel oral anticoagulants (NOACs) that are more convenient, and are at least equally effective and safer (regarding bleeding complications) for stroke prevention compared with vitamin K antagonists (VKAs).
Atrial fibrillation (AF) increases the risk of stroke. The degree of increase can be substantial, depending on the presence of additional risk factors (such as high blood pressure). Atrial fibrillation may be treated with medications to either slow the heart rate to a normal range (rate control) or revert the heart rhythm to normal (rhythm control). The prevalence of AF in a population increases with age, with 8% of people over 80 having AF. Chronic AF leads to a small increase in the risk of death. Nonvalvular atrial fibrillation is AF in the absence of rheumatic mitral valve disease, a prosthetic heart valve, or mitral valve repair.
Patents & Exclusivity
The composition of matter patent covering apixaban in the U.S. expires in February 2023(excluding potential patent term extensions) and in the EU it expires in 2022. The Company has applied for supplementary protection certificates. Some of these supplementary protection certificates have been granted and expire in 2026. Data exclusivity in the EU expires in 2021. The composition of matter patent expires in Canada in 2022. Eliquis has been granted exclusivity by the FDA under the exclusivity code NCE (New Chemical Entity). This exclusivity expires on December 24, 2017. The FDA is precluded by law to approve any ANDA prior this date.
Therapeutic Sector P (IV) Activity
Until recently, the cardiovascular drug sector has been quite active with regard to ANDA filings, with P (IV) certifications averaging about five per year since 2006 - 2010. This trend reflects the fragmented therapeutic environment. We expect the rate of P (iV) certifications to increase through 2018, as brand drugs lose exclusivity and patent protection.
In terms of the overall market growth for novel oral anticoagulants, we expect Eliquis to overtake Pradaxa as the overall market segment leader in 2016. We are also forecasting total global Eliquis revenue to exceed US $4 billion for the year 2017. The result will be a highly attractive generic market for the ANDA first-filer prepared to enter the market at the end of 2017 when the FDA exclusivity period for Eliquis is scheduled to expire.
Generic Revenue Opportunity
We are predicting that the ANDA first-filer entering the market in will capture of the total global market for apixaban drugs for the treatment of AF in calendar year . The majority of sales will come during the 180-day exclusivity period, at a price approximately of the brand price.
Eliquis – The Brand
Apixaban – The Market
Apixaban – The Opportunity
Manufacturing and Sourcing
Eliquis Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic 1st-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario
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